含头孢呋辛方案治疗青霉素过敏的幽门螺杆菌感染患者的单中心前瞻性队列研究  

Cefuroxime-containing regimen in the treatment of Helicobacter pylori infection in patients with penicillin allergy:a single-center prospective cohort study

作　　者：倪益玲 杨秋分 陈彦君[2] 陈冰心[2] 陈卫昌[2] 冯璜[2] Ni Yiling;Yang Qiufen;Chen Yanjun;Chen Bingxin;Chen Weichang;Feng Huang(Department of Gastroenterology,Suzhou Ninth People′s Hospital,Suzhou 215200,China;Department of Gastroenterology,the First Affiliated Hospital of Soochow University,Suzhou Clinical Center of Digestive Diseases,Suzhou 215006,China)

机构地区：[1]苏州市第九人民医院消化内科,苏州215200 [2]苏州大学附属第一医院消化内科、苏州市消化病临床医学中心,苏州215006

出　　处：《中华消化杂志》2024年第4期234-237,共4页Chinese Journal of Digestion

摘　　要：目的通过比较含头孢呋辛与含阿莫西林的铋剂四联方案治疗幽门螺杆菌(H.pylori)的根除率和不良反应发生率,评估头孢呋辛在青霉素皮试阳性的H.pylori感染患者中的疗效和安全性。方法采用前瞻性队列研究,选择2020年12月至2021年12月于苏州大学附属第一医院H.pylori专病门诊接受H.pylori初次根除治疗的患者共498例,根据青霉素过敏史或青霉素皮试结果分为两组,即阿莫西林组(含阿莫西林)和头孢呋辛组(含头孢呋辛)。阿莫西林组纳入394例患者,治疗方案为艾司奥美拉唑镁肠溶片20 mg、枸橼酸铋钾胶囊220 mg、阿莫西林胶囊1 g、克拉霉素缓释片500 mg,2次/d,口服。头孢呋辛组纳入104例患者,治疗方案为艾司奥美拉唑镁肠溶片20 mg、枸橼酸铋钾胶囊220 mg、头孢呋辛酯片500 mg、克拉霉素缓释片500 mg,2次/d,口服。治疗时间均为14 d,治疗结束后4~8周复查13C尿素呼气试验。按意向性治疗集(ITT)分析和符合方案集(PP)分析比较两组的根除率。比较两组不良反应发生率。统计学方法采用卡方检验。结果在ITT和PP分析中,阿莫西林组根除率分别为84.3%(332/394,95%置信区间80.6%~87.6%)和90.5%(332/367,95%置信区间87.2%~93.3%),头孢呋辛组根除率分别为62.5%(65/104,95%置信区间52.7%~71.7%)和69.1%(65/94,95%置信区间58.8%~78.7%),阿莫西林组根除率均高于头孢呋辛组,差异均有统计学意义(χ^(2)=24.11、28.44,均P<0.001)。阿莫西林组和头孢呋辛组的不良反应发生率分别为10.9%(43/394)和14.4%(15/104),差异无统计学意义(P>0.05)。结论头孢呋辛+克拉霉素的铋剂四联方案在青霉素过敏的H.pylori感染患者中未能取得令人满意的根除率。Objective To compare the eradication rate and incidence of adverse reactions between cefuroxime-containing and amoxicillin-containing bismuth quadruple regimen in the treatment of Helicobacter pylori(H.pylori),and to evaluate the efficacy and safety of cefuroxime in the H.pylori infection patients with positive penicillin skin test results.Methods From December 2020 to December 2021,a total of 498 patients who received initial H.pylori eradication treatment at the H.pylori Specialized Outpatient Clinic of the First Affiliated Hospital of Soochow University were selected to participate in this prospective cohort study.According to the history of penicillin allergy or positive penicillin skin test results,the patients were divided into amoxicillin group and cefuroxime group.A total of 394 patients were included in the amoxicillin group,and the treatment regimen was esomeprazole 20 mg,bismuth 220 mg,amoxicillin 1 g and clarithromycin 500 mg orally twice a day.A total of 104 patients were included in the cefuroxime group,and the treatment regimen was esomeprazole 20 mg,bismuth 220 mg,cefuroxime 500 mg and clarithromycin 500 mg orally twice a day.The treatment period was 14 days.13C-urea breath test was conducted during 4 to 8 weeks after the treatment.The eradication rates of the 2 groups were compared by intention-to-treat(ITT)analysis and per-protocol(PP)analysis.The incidence of adverse reactions was compared between the 2 groups.Chi-square test was used for statistical analysis.Results The results of ITT analysis and PP analysis indicated that the eradication rates of amoxicillin group were 84.3%(332/394,95%confidence interval(95%CI)80.6%to 87.6%)and 90.5%(332/367,95%CI 87.2%to 93.3%),respectively,and the eradication rates of cefuroxime group were 62.5%(65/104,95%CI 52.7%to 71.7%)and 69.1%(65/94,95%CI 58.8%to 78.7%),respectively.The eradication rates of amoxicillin group in ITT and PP analysis were both higher than those of cefuroxime group,and the differences were statistically significant(χ^(2)=24.11 and 28.44

关 键 词：螺杆菌 幽门 阿莫西林 头孢呋辛 根除率 

分 类 号：R573[医药卫生—消化系统]